N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9897741
- MDR report key
- 9897741
- Report number
- 3004209178-2020-06369
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-05
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA WOODWARD CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | MEDTRONIC PUERTO RICO OPERATIONS CO. | EZW | 3058 | 3058 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE PATIENT CALLED IN FOR ASSISTANCE WITH THE EXTERNAL DEVICES. PATIENT SERVICES (PS) REVIEWED HOW TO USE THE DEVICES. PATIENT SAID SHE WANTED TO CHANGE TO PROGRAM 2. DURING CALL PS REVIEWED HOW TO CHANGE PROGRAMS AND PATIENT WAS ABLE TO CHANGE TO PROGRAM 2. PATIENT SAID SHE FELT STIM IN HER HIP AND NOT THE BIKE SEAT. PATIENT SAID THEY WERE NEVER ABLE TO GET STIM IN THE BIKE SEAT. ON (B)(6) 2020 THE PATIENT CALLED IN AGAIN AND STATED THAT THEY HAVE BEEN INCONTINENT WITH THE NEW DEVICE AND IT IS NOT WORKING FOR THEIR SYMPTOMS AT ALL. THE PATIENT WAS ABLE TO CHANGE FROM PROGRAM 4 AT 3.5 V TO PROGRAM 5 AT 2.1 V WHERE IT WAS COMFORTABLE. THE PATIENT ALSO STATED THAT THEY WERE UNABLE TO GET THE STIMULATION IN THE BICYCLE SEAT AREA WHEN THEY GOT THE NEW IMPLANT AND WANTED TO KNOW IF PS COULD GET IT THERE. THE PATIENT CHANGED PROGRAMS AND REVIEWED HOW PROGRAMMING MAY NEED TO BE ADDRESSED. THE PATIENT WILL MONITOR SYMPTOMS NOW THAT A CHANGE WAS MADE AND WILL FOLLOW UP WITH HCP IF THE ISSUES DON'T RESOLVE. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.